Dive Brief:

• FDA has authorized the first over-the-counter, at-home molecular test for COVID-19. Cue Health received the emergency authorization for the 20-minute diagnostic for use in symptomatic and asymptomatic individuals, ages two and older.

• The number of at-home diagnostics has grown during the recent phase of the pandemic but most kits test for antigens and require a prescription. Cue is unique in receiving an EUA for OTC use of a molecular nucleic acid amplification test.

• Having raised $100 million and secured a $481 million government award last year to expand its manufacturing footprint, Cue expects to be able to produce more than 100,000 tests a day by the summer of 2021. 

Dive Insight:

Cue has developed a battery-operated reader and associated cartridges to test for infectious diseases in around 20 minutes. The technology came to market for point-of-care use under the supervision of qualified medical personnel last summer, leading to its adoption by schools, nursing homes, hospitals and other organizations.

Now, Cue has received FDA clearance to enable consumers to access the testing capabilities without a prescription. The EUA supports use in symptomatic and asymptomatic people aged two years and up, giving it a similar label to Ellume's OTC antigen test for COVID-19.

Cue received the EUA on the basis of a study that evaluated the ability of 286 people to use the test in simulated home environments. Results were unavailable for 10 of the Cue tests due to reasons such as cartridge flow errors and accidental cancellation by the users.

The available results hewed closely to the findings of a molecular comparator method with EUA. The positive and negative percent agreements (PPA/NPA) were 97.4% and 99.1%, respectively. The PPA and NPA were one percentage point lower in symptomatic individuals and 100% in asymptomatic people. The PPA in asymptomatic people had a wide confidence interval due to the small number of positive tests. Cue showed the test can detect variants of concern such as B.1.1.7, which was first identified in the U.K.

Cue has secured the EUA ahead of most other companies with plans to create a home-testing market in the U.S. Quidel, for example, is working on an OTC, at-home antigen test that analysts see as the first step in the emergence of a consumer-focused diagnostic business, but the need to generate more positive results in asymptomatic individuals has delayed its filing plans. Cue has aspirations to build such a consumer-focused business and now has a head start on Quidel.

"With this FDA authorization, we are one step closer to achieving our mission of making molecular diagnostic testing available to anyone, anywhere, at any time through a connected healthcare delivery ecosystem," Cue CEO Ayub Khattak said in a statement. 

Cue is now racing to make the most of its head start and to help manage the next phase of the pandemic. FDA said Cue expects to make more than 100,000 tests a day by the summer.